Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly
Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure of safety alarms in an implantable medical device, which poses a risk of harm if valve system issues are not detected, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Flowonix Medical Inc is recalling the Prometra Programmable 20mL Pump, Catalog No. 11827. The recall involves 6,670 units distributed domestically in the United States and internationally to the United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. The affected devices are implantable infusion pumps with pump firmware version 0.26 manufactured from 2012 until the present time.
The recall is due to a pump alarm function anomaly in the firmware code. This defect may result in the pump not sending expected error code notifications to the Programmer or failing to emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Patients with these specific implantable infusion pumps should contact their healthcare provider or Flowonix Medical Inc for instructions on how to proceed. The source text does not specify a particular consumer action beyond the standard recall notification process.
The recalled product
- Product
- Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 6,670
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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